SPINS Participates in FDA Public Hearing on Gluten-Free Labeling
On August 19th, 2005, the FDA Center for Food Safety and Applied Nutrition in College Park, MD held an all-day session on "gluten-free" labeling. The purpose of the meeting was to seek public comments from stakeholders as well as the general public in order to define and permit the use of the term in food labeling, and to comply with mandates in FALCPA (Food Allergen Labeling and Consumer Protection Act of 2004). Currently there are no labeling standards relating to gluten-free products sold in the U.S. and this meeting started the formal process for the FDA to propose rules by August 2, 2006 and finalize them by August 2, 2008.
The meeting's focus was on:
• Definitions of Gluten-Free
• Gluten-Free Product Development
• Good Manufacturing Practices (GMP's)
• Consumer Purchasing Practices
SPINS had the unique opportunity of providing the FDA panel with summarized topline sales and growth information for the products in the Natural Supermarket channel and the Conventional Food/Drug/Mass channel over the last 2 years. Other speakers included individuals living with Celiac Disease, as well as non-profit organizations and manufacturers. Sales for the 52 weeks ending July 11, 2005 topped more than $600 million and saw growth of 14.6% year over year. SPINS also found that gluten-free products are driving the growth of several food categories that are flat or in some cases in decline. These figures indicate that there is an abundance of gluten-free products selling successfully in natural and conventional outlets, making consistent industry-wide definitions and labeling of consumer packaged goods necessary.
The session was managed by six panelists from the Food Labeling and Standards Staff, the Division of Natural Products (the Director as well as a Senior Food Scientist) and a Senior Medical Advisor for the Office of Food Additive Safety.
The morning session consisted of an overview of Celiac Disease by Frank Hamilton, M.D., M.P.H. In addition to symptomology, he provided insight into the difficulty doctors have in properly diagnosing the disease. In the U.S. population there are roughly 40,000 diagnosed cases, but the projected number of people with Celiac Disease is over 2 million. In essence, for every diagnosed case, there are 53 undiagnosed cases.
Gluten is found in grains including wheat, barley, rye and oats. Certain individuals are born with a genetic disposition for developing Celiac Disease, an autoimmune response that causes damage to the small intestine. Unless the individual strictly avoids these "grains of concern", the small intestine will lose its ability to absorb the nutrients found in food, leading to malnutrition and a variety of other complications over time.
Following was an industry perspective on a gluten-free labeling standard. Speakers included a representative from the North American Millers Association, which is responsible for over 95% of the U.S. grain production, an executive from Bob's Red Mill Natural Foods, Inc., who offers over 50 gluten-free products, a co-owner from Miss Roben's, a gluten-free product manufacturer and mail-order business, and a Team Leader from the Gluten-Free Bakehouse of Whole Foods Markets. Whole Foods Markets currently distributes 25 gluten-free baked goods to all of their retail stores. FDA Panel questions followed these presentations and focused on how each of the associations defined “gluten-free” and how they guaranteed the products they distributed were gluten-free.
The next session led to a more in-depth discussion on the analytical methods and tests currently used to measure gluten in grains and the varying pro's and con's of each. The two speakers included a plant physiologist from the USDA and a scientist for the Food Products Association. In summary, there are a number of tests available to test grains or finished products for the presence of gluten, but the most popular is ELISA (Enzyme- Linked Immuno Sorbant Assay). Participants testified that the test is sensitive, relatively quick and inexpensive to use, and effective for a variety of unprocessed and heat-processed foods.
The afternoon sessions began with a consumer perspective on gluten-free labeling standards. The three speakers included representatives from the Celiac Sprue Association, the Celiac Research Center (University Of Maryland) and the Celiac Disease Center (Columbia University). Several of these associations surveyed their clients with Celiac Disease to determine the types of packaged foods purchased, and the influence of current gluten-free labeling.
Throughout these sessions, oats were questioned as a legitimate grain for use in gluten-free products. Oats do not technically contain gluten, but due to cross-contamination in the grain milling and storage process, as well as other steps in the manufacturing of finished products, oats often end up testing positive for a small percentage of gluten. The economics of grain milling and product manufacturing make it clear that to isolate or quarantine oats on a large scale would prove very costly. Also, oats are generally avoided by those with Celiac Disease per the advise of their healthcare providers, and only a minority of those in attendance felt that oats should be excluded from the “grains of concern” list.
About SPINS Gluten-Free Data:
SPINS' team of Natural Product Experts has researched more than 10,000 products across many food categories and fully coded more than 2,500 items currently labeled as gluten-free in supermarkets. If you are interested in learning more about SPINS new coding for gluten-free products, please contact your Regional Account Manager or Diana Dixon at 815.609.0607 / ddixon@spins.com.